New Data Presented Evaluating the Use of DEXTENZA Following Cataract
Surgery

BEDFORD, Mass.--(BUSINESS WIRE)--May 8, 2017--
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development, manufacturing and commercialization of
innovative therapies for diseases and conditions of the eye, presented
yesterday new data from its most recent Phase 3 study evaluating the
safety and efficacy of DEXTENZA (dexamethasone insert) 0.4 mg for the
treatment of ocular pain and inflammation following cataract surgery.
The data were released at the American Society of Cataract and
Refractive Surgery Annual Symposium (ASCRS) in Los Angeles, CA.

The U.S. Food and Drug Administration (FDA) has set a target action date
under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017 for a
decision regarding the potential approval of DEXTENZA for the treatment
of ocular pain following ophthalmic surgery.

Primary endpoints included absence of anterior chamber (AC) cells (a
sign of inflammation) at Day 14 and absence of pain at Day 8. Topical
NSAIDs were not permitted. Both endpoints were statistically superior to
placebo, with more than 52% of patients receiving DEXTENZA having no AC
cells at Day 14 compared to 31.1% of placebo subjects. Additionally, 79%
of patients in the DEXTENZA group reported no pain at Day 8 compared to
61.3% of the placebo group. Statistical superiority of DEXTENZA was also
noticed at Day 2 for the absence of ocular pain and Day 4 for the
absence of AC cells. There were no treatment-related serious adverse
events (SAEs) and DEXTENZA was well tolerated in all clinical trials. No
patients experienced any adverse events resulting in study withdrawal.

A cross-sectional, qualitative survey, commissioned by Ocular
Therapeutix, evaluating patient experience of DEXTENZA among 25 patients
from U.S. Phase 3 investigational clinical trials was also presented at
the ASCRS meeting. In the survey, 92% of patients reported the highest
level of overall satisfaction with the product, and would recommend
DEXTENZA to family and friends. Further, 96% of patients reported the
highest level of satisfaction with regard to convenience. Additionally,
84% of patients reported that they would be willing to pay more for
DEXTENZA and would request DEXTENZA again.

“DEXTENZA’s safety and efficacy profile, combined with a positive
patient experience, provide a strong foundation for offering an
alternative to current post-operative steroid eye drops, which are
associated with compliance issues,” said Amar Sawhney, Ph.D., President,
Chief Executive Officer and Chairman of Ocular Therapeutix. “If
approved, DEXTENZA may reduce the patient burden of administering
topical eye drops following ophthalmic surgery by enabling physicians to
control the entire course of steroid therapy with a single
administration.”

The Company also presented data on the importance of pain assessment
following ophthalmic surgery; preservatives in topical ophthalmic
medications used after ocular surgery; a literature review on medical
adherence for glaucoma; and the evaluation of a Phase 3 clinical
development program for OTX-TP, a sustained release travoprost
intracanalicular insert for the treatment of glaucoma and ocular
hypertension.

Phase 3 Study Design

This prospective, multicenter, 1:1 randomized, parallel-arm,
double-masked, vehicle-controlled study was designed to evaluate the
safety and efficacy of DEXTENZA for the treatment of ocular inflammation
and pain following cataract surgery. The study enrolled 438 patients who
were undergoing clear corneal cataract surgery at 21 sites
throughout the United States. Immediately following surgery, patients
were randomized to insertion of either DEXTENZA or a placebo vehicle.
Primary efficacy endpoints evaluated the differences between the
DEXTENZA treatment group and the placebo group for the absence of
anterior chamber cells at day 14 and absence of pain at day 8. Secondary
efficacy endpoints included absence of anterior chamber cells, absence
of ocular flare, and absence of ocular pain across relevant time points
during the 30-day treatment period.

About DEXTENZA™(dexamethasone insert) 0.4 mg for
Intracanalicular Use

DEXTENZA is placed through the punctum, a natural opening in the eye
lid, into the canaliculus and is designed to deliver dexamethasone to
the ocular surface for up to 30 days. Following treatment, DEXTENZA
resorbs and exits the nasolacrimal system without need for removal. The
Company has completed three Phase 3 clinical trials with DEXTENZA for
the treatment of post-surgical ocular inflammation and pain.

Ocular Therapeutix resubmitted an NDA to the FDA for DEXTENZA for the
treatment of ocular pain following ophthalmic surgery, for which
the FDA has set a PDUFA target action date of July 19, 2017. Subject to
the approval of the NDA for post-surgical ocular pain by the FDA, Ocular
Therapeutix intends to submit a supplement to its NDA for DEXTENZA to
broaden its label to include a post-surgical ocular inflammation
indication.

About Ocular Pain and Inflammation Following Ophthalmic Surgery

Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe topical corticosteroids as part
of the standard of post-operative care. If left untreated, inflammation
of the eye may result in further ocular complications, which in some
cases may cause permanent loss of vision. According to US Census data,
by the year 2020 it is estimated that the number of Americans diagnosed
with cataracts is expected to rise to approximately 30 million,
representing a 32% increase over current prevalence estimates.

According to Market Scope, approximately 3.9 million cataract cases and
over 5.6 million ocular surgeries were performed in the United States in
2016.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the
development, manufacturing and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix’s lead product candidate,
DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use has
completed Phase 3 clinical development for the treatment of ocular pain
and inflammation following ophthalmic surgery. The FDA has accepted the
Company’s NDA resubmission for DEXTENZA for the treatment of ocular pain
following ophthalmic surgery and has established a PDUFA target action
date of July 19, 2017. If approved, the Company intends to submit a
supplement to its NDA for ocular inflammation. OTX-TP (travoprost
insert) is in Phase 3 clinical development for glaucoma and ocular
hypertension. Ocular Therapeutix is also evaluating injectable drug
delivery depots for back-of-the-eye diseases. Ocular Therapeutix's first
product, ReSure® Sealant, is FDA-approved to seal corneal
incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans
and prospects for the Company including the development and regulatory
status of the Company’s product candidates, such as the Company’s
expectations and plans regarding regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA™ for the treatment of
post-surgical ocular inflammation and pain, including our expectations
regarding the NDA filed with the FDA and the FDA’s response to the
resubmitted NDA and the potential impact of the re-inspection of
manufacturing operations, DEXTENZA for the treatment of allergic
conjunctivitis, DEXTENZA for the treatment of dry eye disease and OTX-TP
for the treatment of glaucoma and ocular hypertension, the ongoing
development of the Company’s sustained release hydrogel technology, the
potential utility of any of the Company’s product candidates, potential
commercialization of the Company’s product candidates, and other
statements containing the words "anticipate," "believe," "estimate,"
"expect," "intend", "goal," "may", "might," "plan," "predict,"
"project," "target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions, constitute forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
important factors. Such forward-looking statements involve substantial
risks and uncertainties that could cause the Company’s clinical
development programs, future results, performance or achievements to
differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include, among
others, those related to the timing and costs involved in
commercializing ReSure® Sealant or any product candidate that
receives regulatory approval, the initiation and conduct of clinical
trials, availability of data from clinical trials and expectations for
regulatory submissions and approvals, the Company’s scientific approach
and general development progress, the availability or commercial
potential of the Company’s product candidates, the sufficiency of cash
resources and need for additional financing or other actions and other
factors discussed in the “Risk Factors” section contained in the
Company’s quarterly and annual reports on file with the Securities and
Exchange Commission. In addition, the forward-looking statements
included in this press release represent the Company’s views as of the
date of this release. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However, while
the Company may elect to update these forward-looking statements at some
point in the future, the Company specifically disclaims any obligation
to do so. These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the date
of this release.

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